Proof of Concept Study of AX-158 in Patient with mild to moderate plaque psoriasis
Research type
Research Study
Full title
A Phase 2a, proof of concept study evaluating the safety and tolerability of AX-158 in patients with mild to moderate plaque psoriasis
IRAS ID
1007597
Contact name
Fosia Yusuf
Contact email
Sponsor organisation
Artax Bioharma, Inc,
Eudract number
2023-000301-35
Clinicaltrials.gov Identifier
Research summary
Artax Biopharma, Inc. (the Sponsor) are running a Phase 2a, proof of concept study evaluating the safety and
tolerability of AX-158 in patients with mild to moderate plaque psoriasis. This study will be run in 2 study arms, and the participants will be randomised to receive either AX-158 or matching placebo in a 2:1 ratio.The study is planned to involve 30 men or women aged 18 – 60 years old. The target enrolment is approximately 9 participants with mild psoriasis and approximately 21 participants with moderate psoriasis. Study participants will visit the study site 6 times during the study, where they will be asked about medical history and general health. Participants will undergo procedures such as, blood and urine tests, ECGs, and a physical examination including weight and height measurements, skin biopsy and medical photography of the skin lesion.
The study will consist of an up to 28-day screening period, a 28-day treatment period, and a 30-day follow-up period. The total duration of the study for participants remaining in the study until their final follow-up assessment will be approximately 86 days (3 months). Participants will take the AX-158 capsule or matching placebo capsule once daily for 28 days.
Safety will be monitored by the sponsor which will implement a risk-based quality management approach to ensure
the quality of the study, focusing on processes and data that are critical to ensuring participant safety and data integrity. The study will be conducted in accordance with the ethical principles that have their origin in the World Medical Association (WMA) Declaration of Helsinki, and international Good Clinical Practise guidelines.REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0651
Date of REC Opinion
23 Oct 2023
REC opinion
Further Information Favourable Opinion